一、请补充说明公司国有股东履行国有股标识等国资管理程序进展情况。 二、请补充说明公司历次增资及股权转让价格、定价依据及价格差异原因，是否存在对价异常，并就公 司设立及历次股权变动是否合法合规出具结论性意见。 三、请公司结合药物研发技术路线等情况说明公司及下属公司经营范围、实际业务是否涉及"人体干细 胞、基因诊断与治疗技术开发和应用"或其他外商投资准入限制或禁止领域及相关判断依据，本次发行 上市及"全流通"前后是否持续符合外商投资准入政策要求。 智通财经APP获悉，12月26日，中国证监会发布《境外发行上市备案补充材料要求(2025年12月22日— 2025年12月26日)》。中国证监会国际司公示19家企业补充材料要求，其中，要求时迈药业补充说明公 司国有股东履行国有股标识等国资管理程序进展情况等事项。据港交所11月12日披露，浙江时迈药业股 份有限公司-B(简称：时迈药业)递表港交所主板，华泰国际为其独家保荐人。 证监会请时迈药业补充说明以下事项，请律师核查并出具明确的法律意见： 四、请补充说明本次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他权利瑕疵的情形。 据招股书，该公司成立于2017年，是下一 ...

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor [1]. Company Overview - Established in 2017, the company is a pioneer and global leader in next-generation T-cell engagers (TCE) therapy, designed to direct T-cells to tumor tissues and activate them to induce targeted cytotoxic effects [3][4]. - The company has developed a next-generation TCE therapy that selectively activates in tumors for the treatment of solid tumors, with a significant market potential [3][4]. Product Pipeline - As of November 5, 2025, the company has four clinical-stage candidates: 1. DNV3, targeting LAG3 2. SMET12, an intravenous EGFR×CD3 TCE 3. CMD011, a GPC3×CD3 TCE 4. CMDE005, a next-generation EGFR×CD3 TCE [4]. - Additionally, two preclinical candidates are in development, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3 [4]. Financial Performance - The company reported revenues of RMB 14.649 million, RMB 6.618 million, and RMB 2.278 million for the years 2023, 2024, and the first half of 2025, respectively [7][9]. - Losses for the same periods were RMB 74.943 million, RMB 59.899 million, and RMB 25.420 million [7][9]. - Research and development expenses were RMB 76.109 million, RMB 53.382 million, and RMB 22.389 million for the years 2023, 2024, and the first half of 2025, respectively [8][9]. Market Overview - The global TCE market is projected to grow from USD 4 billion in 2020 to USD 30 billion in 2024, with a compound annual growth rate (CAGR) of 67.6% [12]. - By 2035, the global TCE market is expected to reach USD 121.1 billion [12]. - The Chinese TCE market is anticipated to grow from RMB 1 billion in 2021 to RMB 7 billion in 2024, with a CAGR of 104.0% [12]. By 2035, it is expected to reach RMB 159.6 billion [12]. Board of Directors - The board consists of 9 members, including 3 executive directors, 3 non-executive directors, and 3 independent non-executive directors [15].